Methylene Blue Treatment of COVID-19

What Was Tested

The trial (phase 2) is built around Methylene blue (non-peptide stack partner).

Repurposing of well known, widely available drugs represent an attractive approach to speed up availability of active treatments.

Such substances as i.e. hydroxychloroquine and others, are already under investigation and in widespread off label use.

It had two arms (groups): Methylene Blue (experimental) and control group (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 29 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent. Age ≥ 18 years. Microbiologically confirmed SARS-CoV-2 infection. Negative pregnancy test in women of child-bearing age.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: documented refusal to participate in the study; known g-6-phophatase deficiency; treatment with a serotoninergic drug.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: care provider, investigator and outcomes assessor.

It started in 2020-11-05 with completion listed for 2021-08-13.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example To calculate the percentage of patients clearing SARS-CoV-2 by 3, 6, 9, 12, 15 and 21 days after diagnosis, To calculate the percentage of patients having a poor outcome as measured by the need of hospitalization for COVID-19 and To calculate the percentage of patients alive.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.